1. Field
This invention pertains to an electrolytic method and apparatus for producing electrolyzed saline redox-balanced solutions. More particularly, it pertains to a method and apparatus used to produce a stable, non-toxic, antimicrobial electrolyzed saline redox-balanced solution from pure saline or hypertonic saline (NaCl and H2O), both referred to hereafter as saline solution, exhibiting anti-infective and immune-enhancing potential as a therapeutic employing a balanced mixture of chemically reduced and oxidized species including Hypochlorous acid (HOCl), Hypochlorites (OCl−, NaClO), dissolved Oxygen (O2), Chlorine (Cl2) and Hydrogen (H2) gases, Hydrogen Peroxide (H2O2), Hydrogen ions (H+), Hypochloride (ClO) and corresponding amounts of Superoxides (*O2−, HO2), Ozone (O3), Activated Hydrogen ions (H−), Chloride ions (Cl−), Hydroxides (NaOH, OH−), Singlet Oxygen (*O2) and other forms of Reactive Oxygen Species (ROS) (*OCl, *HO−).
2. State of the Art
Electrolysis of saline solutions has long been used to produce antimicrobial solutions that are compatible with mammalian biology. Some examples include methods to produce chlorinated water, bleach and hydrogen peroxide. Typically, the methods and apparatus used to electrolyze these solutions employ ion-selective barriers between the electrodes in order to efficiently isolate the target molecules and eliminate unwanted byproducts. A fundamentally different method and apparatus for producing a non-toxic antimicrobial electrolyzed saline solution is disclosed in eight United States patents, and two Japanese patents and a Mexican patent based on these U.S. patents, all held by the applicant, covering various other applications for intravenous injected electrolyzed saline solution, the machinery that manufactures it, and the method by which it is manufactured. These U.S. patents are as follows:                U.S. Pat. No. 5,334,383, Morrow, dated Aug. 2, 1994 entitled “Electrically Hydrolyzed Salines as In Vivo Microbicides for Treatment of Cardiomyopathy and Multiple Sclerosis.” This patent covers a method of treating antigen related infections related to cardiomyopathy and multiple sclerosis in humans and other warm blooded animals. It does not cover the substance itself, but covers a particular use of the substance. This method of treatment includes the use of an electrolyzed saline solution in conjunction with one or more modulating agents such as ascorbic acid (Vitamin C), with or without concurrent colchicine, to mimic or enhance the body's naturally occurring immune response to bacterial, viral or fungal infection.        U.S. Pat. No. 5,507,932, dated Apr. 16, 1996 entitled “Apparatus for Electrolyzing Fluids.” This patent covers equipment that exposes a liquid solution to an electrical current, creating an electrolyzed solution. This equipment may be used to produce an electrolyzed saline solution, capable of killing bacterial, viral and fungal agents, for use in medical applications such as the treatment of antigen related infections in humans and other warm blooded animals. This patent covers the equipment used to produce the electrolyzed saline solution, not the substance itself.        U.S. Pat. No. 5,560,816, Robinson, dated Oct. 1, 1996 entitled “Method for Electrolyzing Fluids.” This patent covers a method for electrolyzing fluids, by using specialized equipment to expose liquid solutions to an electrical current. Saline, for example, may be treated by this process to yield an electrolyzed saline solution, capable of killing bacterial, viral and fungal agents, for the treatment of antigen related infection in humans and other warm blooded animals. This patent covers the method by which the electrolyzed saline solution is produced, not the substance itself.        U.S. Pat. No. 5,622,848, Morrow, dated Apr. 22, 1997 entitled “Electrically Hydrolyzed Saline Solutions As Microbicides For In Vitro Treatment Of Contaminated Fluids Containing Blood.” This patent covers a method of treating whole blood and other blood products with an electrolyzed saline solution to reduce infection with bacterial, viral and fungal agents. This patent covers a particular use of the electrolyzed saline solution, not substance itself.        U.S. Pat. No. 5,674,537, Morrow, dated Oct. 7, 1997 entitled “An Electrolyzed Saline Solution Containing Concentrated Amounts Of Ozone And Chlorine Species.” This patent covers a specific electrolyzed saline solution containing a regulated amount of microbicidal agents including ozone and active chlorine species. This solution is intended for use in the treatment of infections in the body of humans and other warm blooded animals, or in blood or blood products. This patent covers the electrolyzed saline solution.        U.S. Pat. No. 5,731,008, Morrow, dated Mar. 24, 1998 entitled “Electrically Hydrolyzed Salines as Microbicides.” This patent covers a method of using a specific electrolyzed saline solution containing a regulated amount of microbicidal agents including ozone and active chlorine species for the treatment of microbial infections, including HIV infection. The method includes intravenous administration of the solution along with one or more modulating agents such ascorbic acid (Vitamin C), with or without concurrent colchicine. This patent covers a method for using the electrolyzed saline solution, not the substance itself.        U.S. Pat. No. 6,007,686, Welch et al, dated Dec. 28, 1999 entitled “System for Electrolyzing Fluids for Use as Antimicrobial Agents.” This patent covers a system for electrolyzing fluids, such as a saline solution, for use in sterilizing dental and medical instruments and other health care equipment. The patent covers the necessary equipment for generating and circulating the electrolyzed saline solution around the instruments to be sterilized, and includes specific claims for equipment designed for use with dental drill hand pieces and flexible tubing. This patent covers a process by which the electrolyzed saline solution may be made for a particular use, not the substance itself.        U.S. Pat. No. 6,117,285, Welch et al, dated Sep. 12, 2000 entitled “System for Carrying Out Sterilization of Equipment.” This patent covers a system for cleaning and sterilizing medical and dental instruments to prevent the spread of infection from one patient to another. The covered system bathes the instrument in an electrolyzed saline solution and causes the solution to flow into and sterilize any openings in the equipment. It includes specific claims for systems designed specifically for the sterilization of dental drills and flexible tubing. This patent covers a particular use of the electrolyzed saline solution, not the substance itself.        
Two Japanese and one Mexican patents provide corresponding coverage in those countries for several of the above U.S. patents. Applicants also have other pending applications with the US Patent and Trademark Office for patents on various treatment uses of the electrolyzed saline solution.
The above embodiments of these prior patents typically have produced measurably different variations of electrolyzed saline solution. Each variation, however, exhibited some antimicrobial action and many of these devices produced solutions with measurable amounts of the components (chlorine, pH, ozone, etc.) within the range of the disclosed regulated amounts. The resulting electrolyzed saline compositions, however, have not historically been satisfactorily consistent or controllable, specifically regarding the concentrations of Reactive Oxygen Species (ROS). In addition, these prior inventions could produce toxic chemicals (chlorates) in the process of electrolyzing the saline solution. Consequently, there is a need for an improved manufacturing method and apparatus, such as that described below, to consistently produce solutions suitable for therapeutic applications in humans and warm-blooded animals.